Penfield Search Partners
Our client is a leader in the Next-Generation Sequencing and Diagnostics technologies that have the potential to impact data analysis and patient care across many therapeutic areas and disease states. They are currently seeking experienced Statisticians either at the Staff or Senior Staff level to provide statistical support for product development, analytical and clinical validation studies to achieve regulatory approval of in vitro diagnostic and companion diagnostic assays in the US and internationally (including FDA PMA, 510(k), and equivalent EU approval). In this role you will:
- Design statistical aspects of studies, write statistical analysis plans, analyze data, write statistical reports and statistical content for regulatory submissions,
collaborate with cross-functional teams on study designs, strategies, and analysis approaches consistent with best statistical practices and regulatory requirements
- Consult on complex study design and proposal development, planning, and strategy for companion diagnostic product development and validation
- Provide statistical designs for clinical or analytical studies based on regulatory guidance or CLSI (Clinical and Laboratory Standards Institute) standards
- Write, review and edit statistical analysis plans and study reports
- Utilize appropriate statistical methodologies and techniques to analyze data and summarize data analysis results orally and in written form
- Support responses to statistical queries from regulatory bodies
- Participate in project team meetings
- Lead internal Biostatistics meetings and Biostatistics-related meetings with teams outside Biostatistics
- Create all relevant documentation pertaining to statistical design and analysis at a level consistent with auditable standards in the IVD industry
Requirements
- Master’s degree in Biostatistics, Statistics and 6+ years’ experience; PhD 3+ years; Senior Staff: MS 8+, PhD 6+
- Experience in planning, analyzing, and reporting of clinical studies in the diagnostic industry preferred
- Experience with companion diagnostics is desirable
- Proficiency in at least one statistical analysis software package (e.g. SAS, JMP scripting, R)
- Able to prioritize work and complete deliverables to timelines with minimal or no supervision
- Experienced in and full understanding of at least one area of Statistics: clinical or analytical studies for in vitro diagnostics (IVDs); companion diagnostics; ROC analysis; linear models including analysis of variance and regression analysis; sample size/power estimation; Design of Experiments (DOE), clinical trials; randomized controlled studies; observational studies; missing data imputation; and survival analysis.
- Knowledge of and experience in applying CLSI and other related regulatory guidance/standards